NDC 0173-0663

EPIVIR HBV

Lamivudine

EPIVIR HBV is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Lamivudine.

Product ID0173-0663_4909c2fe-d6d5-4980-80ec-8ef0ff9ed574
NDC0173-0663
Product TypeHuman Prescription Drug
Proprietary NameEPIVIR HBV
Generic NameLamivudine
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date1998-12-23
Marketing CategoryNDA / NDA
Application NumberNDA021004
Labeler NameGlaxoSmithKline LLC
Substance NameLAMIVUDINE
Active Ingredient Strength5 mg/mL
Pharm ClassesHepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0173-0663-00

240 mL in 1 BOTTLE (0173-0663-00)
Marketing Start Date1998-12-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0173-0663-00 [00173066300]

EPIVIR HBV SOLUTION
Marketing CategoryNDA
Application NumberNDA021004
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1998-12-23

Drug Details

Active Ingredients

IngredientStrength
LAMIVUDINE5 mg/mL

OpenFDA Data

SPL SET ID:2df7349c-f5d7-47b5-d29b-1b6b31985591
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 242692
  • 213483
  • 213484
  • 205328
  • UPC Code
  • 0301730662002
  • Pharmacological Class

    • Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    • Nucleoside Analog [EXT]
    • Nucleoside Reverse Transcriptase Inhibitors [MoA]

    NDC Crossover Matching brand name "EPIVIR HBV" or generic name "Lamivudine"

    NDCBrand NameGeneric Name
    53808-0893EPIVIR HBVEPIVIR HBV
    0173-0662EPIVIRlamivudine
    0173-0663EPIVIRlamivudine
    21695-367EPIVIRlamivudine
    49702-203EPIVIRlamivudine
    49702-204EPIVIRlamivudine
    49702-205EPIVIRlamivudine
    50090-0550EPIVIRlamivudine
    0904-6583LAMIVUDINElamivudine
    10135-605LamivudineLamivudine
    31722-001lamivudinelamivudine
    31722-752LamivudineLamivudine
    31722-753LamivudineLamivudine
    31722-754LamivudineLamivudine
    33342-001LamivudineLamivudine
    33342-002LamivudineLamivudine

    Trademark Results [EPIVIR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EPIVIR
    EPIVIR
    78906783 3227835 Live/Registered
    VIIV HEALTHCARE COMPANY
    2006-06-13
    EPIVIR
    EPIVIR
    74213040 1981308 Live/Registered
    VIIV HEALTHCARE COMPANY
    1991-10-11

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